Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
MHLW Global Strategy Aims at Regulatory Shortcut for Japan-OK’ed Drugs
The Ministry of Health, Labor and Welfare (MHLW) released its international harmonization strategy on June 26, which aims to simplify regulatory procedures in Asian economies for medicines already approved in Japan. “It is a concrete and significant strategy that can…
To read the full story
Related Article
- PMDA Unveils New International Strategy
June 30, 2015
- LDP Eyes Filing of 15 Sakigake Designated Products by FY2018
June 9, 2015
- LDP Weighs Clinical Development Infrastructure Utilizing Patient Registry
April 24, 2015
- MHLW Pursuing Quick Approval of Japan-OK’ed Drugs in Emerging Markets
February 10, 2015
REGULATORY
- Japan Panel Backs Daiichi’s MMR Vaccine, Haihe’s PI3Kα Inhibitor, MSD’s HIV Med
March 3, 2026
- MHLW Revises Guidance on Pediatric Development Plans under Amended PMD Act
March 3, 2026
- MHLW Details New Operational Rules for Conditional Approvals from May
March 3, 2026
- MHLW Seeks Sponsors to Develop 8 “Drug-Loss” Products
March 2, 2026
- WG Members Urge Domestic Biologic Production as National Growth Strategy
March 2, 2026
Japan’s FY2026 drug pricing reform will, for the first time, apply the “G1” price cut rule for long-listed original biologics…
I recently sat down with one of the leading medical directors in Japan to discuss the critical evolution of the medical science liaison (MSL) role.The MSL has transformed from a scientific resource into a strategic partner essential for successful product…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
The Japanese government on March 7 announced new NHI prices to be applied in the FY2025 drug price revision, revealing…
The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…
Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…